Overview
- 15 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-06.
At a glance
Inspections
15
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Feb 2024 – 6 Feb 2024 | Human Drugs | Clean | |
| 23 May 2022 – 9 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jul 2018 – 8 Aug 2018 | Human Drugs | WL | |
| 21 Sep 2016 – 28 Sep 2016 | Human Drugs | 483 | View 483 → |
| 6 Apr 2015 – 10 Apr 2015 | Human Drugs | Clean | |
| 3 Apr 2013 – 5 Apr 2013 | Human Drugs | Clean | |
| 20 Dec 2012 | Not recorded | Clean | |
| 21 Dec 2011 | Not recorded | Clean | |
| 23 Sep 2010 | Not recorded | Clean | |
| 29 Mar 2010 | Not recorded | 483 | View 483 → |
| 9 May 2009 | Not recorded | Clean | |
| 22 Apr 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Mar 2010
21 CFR 820.20(c)
Management review accomplishment
Cited by Margaret Torres-Vazquez, Lorelei S Jarrell
29 Mar 2010
21 CFR 820.22
Quality Audits - defined intervals
Cited by Margaret Torres-Vazquez, Lorelei S Jarrell
29 Mar 2010
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Margaret Torres-Vazquez, Lorelei S Jarrell
Investigators
FDA investigators tied to this site in the record.
Russell K Riley4 insp.
Brian D Nicholson2 insp.
Margaret Torres-Vazquez2 insp.
Jeanne J Thai1 insp.
Jesse A Vazquez1 insp.
Debra L Boyd Seale1 insp.
Debra I Love1 insp.
Bryan L Mcguckin1 insp.
Nicole S Williams1 insp.
Christopher D Leach1 insp.
Lorelei S Jarrell1 insp.
Jason F Chancey1 insp.
Phung T Nguyen1 insp.
Karen E Masley-Joseph1 insp.
Joan A Loreng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxter Healthcare Corporation's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat